It estimated that almost twenty four million people in the United States have diabetes. The most common form of diabetes is type 2 diabetes. In adults, 90 to 95% of the people with diabetes have type 2 diabetes. Type 2 diabetes is a chronic condition that affects the way the body metabolizes sugar (glucose), the body's main source of fuel. With type 2 diabetes, the body is resistant to the effects of insulin or the body produces some insulin, but in insufficient amounts to maintain a normal glucose level. This is known as insulin resistance. (Insulin is a hormone that regulates the absorption of sugar into the body.) If type 2 diabetes is left untreated, the consequences can be deadly. Unfortunately, type 2 diabetes is on the rise. This is fueled largely by the current obesity epidemic.
In recent years, the medical community has made inroads in the fight against type 2 diabetes. Specifically, gastric bypass studies in rats and humans have shown that an endoscopically implanted barrier device such as a sleeve within the lumen of the duodenum causes a marked reduction in insulin dependence and hence a greater improvement in the control of type 2 diabetes. In short, the sleeve acts as a barrier to prevent nutrients from being absorbed by the lining of the duodenum. Current methods for securing the barrier sleeve within the lumen involve anchoring the device to the wall of the gastrointestinal tract. In this approach, the sleeve is actually implanted into tissue of the wall using clips, sutures, struts, barbs or other implantable anchoring devices. However, this method of securing the sleeve has not been effective over the long term. In some circumstances, the sleeve has dislodged after implantation and has migrated down into the gastrointestinal tract. In other circumstances, the specific areas in which the sleeve is implanted have become inflamed, and removal has become difficult. Dislodgement and/or inflammation cause serious complications for the patient.
It would be therefore desirable to offer a solution that would overcome the disadvantages of the method described above.